Trial Outcomes & Findings for Omega-3 Fatty Acids for Smoking Cessation in Pregnancy (NCT NCT04417595)
NCT ID: NCT04417595
Last Updated: 2026-06-04
Results Overview
Gestational age at randomization will be determined on the basis of the last menstrual period and earliest ultrasound examination and will not be revised after being assigned a study group. Gestational age will be estimated from the last menstrual period (LMP) and adjusted for the first-trimester ultrasound. If a self-reported LMP is greater than 7 days from the calculated ultrasound LMP, the ultrasound will be used to assign gestational age.
COMPLETED
PHASE2
237 participants
At delivery
2026-06-04
Participant Flow
Participant milestones
| Measure |
Fish Oil
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
Olive Oil
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
|---|---|---|
|
Overall Study
STARTED
|
117
|
120
|
|
Overall Study
COMPLETED
|
110
|
105
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Omega-3 Fatty Acids for Smoking Cessation in Pregnancy
Baseline characteristics by cohort
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
Total
n=237 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.67 years
STANDARD_DEVIATION 4.90 • n=9 Participants
|
29.81 years
STANDARD_DEVIATION 5.49 • n=27 Participants
|
30.25 years
STANDARD_DEVIATION 5.12 • n=267 Participants
|
|
Sex: Female, Male
Female
|
120 Participants
n=9 Participants
|
117 Participants
n=27 Participants
|
237 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=9 Participants
|
99 Participants
n=27 Participants
|
201 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=9 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
4 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=9 Participants
|
117 participants
n=27 Participants
|
237 participants
n=267 Participants
|
PRIMARY outcome
Timeframe: At deliveryPopulation: Randomized participants
Gestational age at randomization will be determined on the basis of the last menstrual period and earliest ultrasound examination and will not be revised after being assigned a study group. Gestational age will be estimated from the last menstrual period (LMP) and adjusted for the first-trimester ultrasound. If a self-reported LMP is greater than 7 days from the calculated ultrasound LMP, the ultrasound will be used to assign gestational age.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Gestational Age at Delivery
|
38.33 weeks
Standard Deviation 1.90
|
38.09 weeks
Standard Deviation 1.60
|
PRIMARY outcome
Timeframe: At 12 weeksPopulation: Analyzed participants who completed 12-week survey prior to delivery
Percentage change from baseline in cigarettes per day (CPD) at 12 weeks. The outcome will be determined based on participant self-report.
Outcome measures
| Measure |
Olive Oil
n=81 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=82 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Change in Cigarettes Per Day
|
36.77 Percent change in CPD
Standard Deviation 83.97
|
35.24 Percent change in CPD
Standard Deviation 86.06
|
SECONDARY outcome
Timeframe: At deliveryObtained from medical record review of delivery records by study personnel blinded to treatment allocation. This will be a categorical variable (yes or no). Outcomes will be adjudicated by study obstetricians blinded to treatment allocation.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Neonates With Fetal Death and Still Birth
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At deliveryPopulation: Neonates
Obtained from medical record review of delivery records by study personnel blinded to treatment allocation. Birth weight will be collected in kilograms.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Individualized Birth Weight
|
111.39 ounces
Standard Deviation 20.54
|
108.69 ounces
Standard Deviation 19.98
|
SECONDARY outcome
Timeframe: At deliveryThe Apgar score is a rapid assessment of a newborn's health at 1 and 5 minutes after birth, evaluating five criteria-Appearance (skin color), Pulse (heart rate), Grimace (reflexes), Activity (muscle tone), and Respiration (breathing). Each of the 5 criteria (APGAR) is scored 0, 1, or 2, totaling a minimum score of 0 and maximum of 10 points. A score of 7-10 is considered normal, indicating good to excellent. A score of 0-3 is critically low, indicating the need for immediate medical intervention. The score will be obtained from medical record review of delivery records by study personnel blinded to treatment allocation.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Apgar Score (5 Minute)
|
8.62 score on a scale (Apgar 5)
Standard Deviation 0.95
|
8.45 score on a scale (Apgar 5)
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: At deliveryObtained from medical record review of delivery records by study personnel blinded to treatment allocation. This will be a categorical variable (yes or no). Outcomes will be adjudicated by study obstetricians blinded to treatment allocation.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Neonates With Intraventricular Hemorrhage
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At deliveryObtained from medical record review of delivery records by study personnel blinded to treatment allocation. This will be a categorical variable (yes or no). Outcomes will be adjudicated by study obstetricians blinded to treatment allocation.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Neonates With Neonatal Enterocolitis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At deliveryObtained from medical record review of delivery records by study personnel blinded to treatment allocation. This will be a categorical variable (yes or no). Outcomes will be adjudicated by study obstetricians blinded to treatment allocation.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Neonates With a Congenital Abnormality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At deliveryObtained from medical record review of delivery records by study personnel blinded to treatment allocation. This will be a categorical variable (yes or no). Outcomes will be adjudicated by study obstetricians blinded to treatment allocation.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Neonates With Neonatal Respiratory Distress
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At deliveryObtained from medical record review of delivery records by study personnel blinded to treatment allocation. This will be a categorical variable (yes or no). Outcomes will be adjudicated by study obstetricians blinded to treatment allocation.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Participants With Maternal Mortality
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At deliveryObtained from medical record review of delivery records by study personnel blinded to treatment allocation. This will be a categorical variable (yes or no). Outcomes will be adjudicated by study obstetricians blinded to treatment allocation.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Participants Requiring Cesarean Delivery
|
36 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: At deliveryObtained from medical record review of delivery records by study personnel blinded to treatment allocation. This will be a categorical variable (yes or no). Outcomes will be adjudicated by study obstetricians blinded to treatment allocation.
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Participants Developing Hypertension in Pregnancy
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Analyzed participants who completed 12-week survey prior to delivery
Point prevalence abstinence at 12 weeks will be based on self-reported smoking cessation and biochemically confirmed by end-expired carbon monoxide (end-expired CO less than 4 ppm)
Outcome measures
| Measure |
Olive Oil
n=81 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=82 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Participants Reaching Point Prevalence Abstinence
|
2 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: At 12 weeksPopulation: Percentage of participants with a decrease in Fagerström Test for Nicotine Dependence (summation score is lower at 12 weeks compared to baseline).
Changes in nicotine dependence based on changes in the Fagerström Test for Nicotine Dependence. The Fagerström Test for Nicotine Dependence is a 6-question scale used to assess the intensity of physical addiction to nicotine. Minimum score is 0 which indicates very low dependence and maximum score is 10 which indicates very high dependence. Each question allows for different categorical responses which are assigned a point value. The points are summed to create a summary score. The score at clinical visit 2 (12 weeks after the baseline/randomization visit) are compared to those at clinical visit 1 (baseline/randomization visit). Differences in score were categorized as an increase in score (increasing dependence), no change in score, or a decrease in score (decreasing dependence),
Outcome measures
| Measure |
Olive Oil
n=120 Participants
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
Fish Oil
n=117 Participants
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
|---|---|---|
|
Percent of Patients With a Decrease in Self-reported Nicotine Dependence
|
50 Participants
|
52 Participants
|
Adverse Events
Fish Oil
Olive Oil
Serious adverse events
| Measure |
Fish Oil
n=117 participants at risk
Participants allocated to n-3 LCPUFA supplementation will be instructed to take four 1000 mg n-3 LCPUFA capsules (Metagenics™) daily. This will provide a total daily dose of 4000 mg n-3 LCPUFAs (2840 EPA and 1160 DHA).
Fish Oil (Containing Omega-3 Acids): Fish Oil Supplement
|
Olive Oil
n=120 participants at risk
Oleic acid (olive oil) capsules have a similar texture, size, color, and consistency to EPA capsules. Participant will be instructed to take four 100mg olive oil capsules
Olive Oil: Olive Oil Supplement
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Fetal Demise
|
0.00%
0/117 • Approximately 9 months from start of study to end of study follow-up
Adverse events presented in this section include maternal adverse events. Adverse events for neonates are reported as secondary outcomes
|
0.83%
1/120 • Number of events 1 • Approximately 9 months from start of study to end of study follow-up
Adverse events presented in this section include maternal adverse events. Adverse events for neonates are reported as secondary outcomes
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place